Study 3 was a double-blind, placebo-controlled, parallel-group study conducted at 47 centers in europe comparing keppra 3000 mg day n 180 and placebo n 104 in patients with refractory partial onset seizures, with or without secondary generalization, receiving only one concomitant aed.
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The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditionsbut the absolute risk differences were similar for the epilepsy and psychiatric indications.
The precise mechanism(sby which levetiracetam exerts its antiepileptic effect is unknownThe antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizuresLevetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold testsProtection was observedhoweveragainst secondarily generalized activity from focal seizures induced by pilocarpine and kainic acidtwo chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalizationLevetiracetam also displayed inhibitory properties in the kindling model in ratsanother model of human complex partial seizuresboth during kindling development and in the fully kindled stateThe predictive value of these animal models for specific types of human epilepsy is uncertain.
Serious dermatological reactionsincluding Stevens-Johnson syndromeSJSand toxic epidermal necrolysisTENhave been reported in both pediatric and adult patients treated with KEPPRAThe median time of onset is reported to be 14 to 17 daysbut cases have been reported at least four months after initiation of treatmentRecurrence of the serious skin reactions following rechallenge with KEPPRA has also been reportedKEPPRA should be discontinued at the first sign of a rashunless the rash is clearly not drug-relatedIf signs or symptoms suggest SJS/TENuse of this drug should not be resumed and alternative therapy should be considered.
Levetiracetam has minor or moderate influence on the ability to drive and use machinesDue to possible different individual sensitivitysome patients might experience somnolence or other central nervous system related symptomsespecially at the beginning of treatment or following a dose increaseThereforecaution is recommended in those patients when performing skilled taskse.gdriving vehicles or operating machineryPatients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
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